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Transcept Pharmaceuticals to Present at BMO Capital Markets Healthcare Conference on August 5, 2009
Date:7/22/2009

ion of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo(R) uses approximately one-quarter to one-third of the dose of active drug contained in currently marketed zolpidem-based sleep aids, in a formulation designed to promote rapid sublingual absorption. As compared to placebo, two Phase 3 clinical studies of Intermezzo(R) showed a statistically significant reduction in the time it took patients to return to sleep after a middle of the night awakening, and there were no significant residual effects upon awakening four hours after dosing. Transcept believes that Intermezzo(R), by combining the reduced zolpidem dose with administration only on those nights when a middle of the night awakening actually occurs, has the potential to reduce unnecessary sedative-hypnotic exposure.

The U.S. Food and Drug Administration (FDA) has established October 30, 2009 as its target date under PDUFA (the Prescription Drug User Fee Act) to take action on its review of the New Drug Application (NDA) for Intermezzo(R). Transcept is actively pursuing patents to protect Intermezzo(R) in the United States and key non-U.S. markets, and, as part of the NDA submission, has requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo(R).

About Middle of the Night Awakenings

Waking up during the night is the most frequent insomnia symptom reported in the general population. Based on a recently published epidemiological study of nearly 9,000 individuals, the Stanford Sleep Epidemiology Research Center has estimated that about one-third of adults in the United States experience middle of the night awakenings at least three times each week. The study concluded that more than 90 percent of those subjects who experienced middle of the night awakenings reported that this insomnia symptom persiste
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SOURCE Transcept Pharmaceuticals, Inc.
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